EP0846472A1 - Catheter balloon bonding stopper - Google Patents
Catheter balloon bonding stopper Download PDFInfo
- Publication number
- EP0846472A1 EP0846472A1 EP97309826A EP97309826A EP0846472A1 EP 0846472 A1 EP0846472 A1 EP 0846472A1 EP 97309826 A EP97309826 A EP 97309826A EP 97309826 A EP97309826 A EP 97309826A EP 0846472 A1 EP0846472 A1 EP 0846472A1
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- EP
- European Patent Office
- Prior art keywords
- shaft
- distal
- proximal
- tail
- catheter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1034—Joining of shaft and balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0014—Connecting a tube to a hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Child & Adolescent Psychology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A medical catheter comprising a catheter shaft 80
defining an inflation lumen 25 and a guidewire shaft 70
defining a guidewire lumen 65. The guidewire shaft is
coaxial with the catheter shaft and runs longitudinally
through the catheter shaft extending distally beyond the
distal end of the catheter shaft. The catheter has an
inflatable balloon 35 having a proximal tail and a
distal tail. The proximal tail is mounted at the distal
end of the catheter shaft, the distal tail is mounted on
the guidewire shaft. The balloon is in fluid
communication with the inflation lumen. A stopper means
30,50 is sealingly affixed between the outer diameter of
the guidewire shaft and the inner diameter of the
proximal and/or distal tail. The distal and proximal
stopper means 50,30 are annular in shape and are in
length shorter than the balloon tail and are of uniform
circumferential thickness. An adhesive 5,10 seals a
portion of the tails to the catheter shaft 80.
Description
The present invention relates to angioplasty
catheters, and more particularly, to a catheter balloon
bond at the balloon proximal or distal end.
One of the therapeutic procedures applicable to the
present invention is known as percutaneous transluminal
coronary angioplasty (PTCA). This procedure can be
used, for example, to reduce arterial build-up of
cholesterol fats or atherosclerotic plaque. Typically a
first guidewire of about 0.95mm (.038 inches) in
diameter is steered through the vascular system to the
site of therapy. A guiding catheter, for example, can
then be advanced over the first guidewire to a point
just proximal of the stenosis. The first guidewire is
then removed. A balloon catheter on a smaller 0.35mm
(.014 inch) diameter second guidewire is advanced within
the guiding catheter to a point just proximal of the
stenosis. The second guidewire is advanced into the
stenosis, followed by the balloon on the distal end of
the catheter. The balloon is inflated causing the site
of the stenosis to widen. The original catheter can
then be withdrawn and a catheter of a different size or
another device such as an atherectomy device can be
inserted.
Conventional angioplasty balloons fall into high,
medium, and low pressure ranges. Low pressure balloons
are those that have burst pressures below 6.1 x 105
Pascals (6 atmospheres) . Medium pressure balloons are
those that have burst pressures between 6.1 x 105 and 1.2
x 106 Pa (6 and 12 atm) . High pressure balloons are
those that have burst pressures above 1.2 x 106 Pa (12
atm). Burst pressure is determined by such factors as
wall thickness and tensile strength, for example.
High pressure balloons are desirable because they
have the ability to exert more force and crack hard
lesions. High pressure balloons are also useful in
stent deployment. A biocompatible metal stent props open
blocked coronary arteries, keeping them from reclosing
after balloon angioplasty. A balloon of appropriate
size and pressure is first used to open the lesion. The
process is repeated with a stent crimped on a high
pressure balloon. The stent is deployed when the
balloon is inflated. A high pressure balloon is useful
for stent deployment because the stent must be forced
against the artery's interior wall so that it will fully
expand thereby precluding the ends of the stent from
hanging down into the channel encouraging the formation
of thrombus.
Many bonding techniques for bonding a balloon to a
shaft, as for example, laser welding or heat bonding,
require thermally similar materials. Adhesive bonds are
useful when bonding materials that have different
thermal characteristics. For example, a polyethylene
terephthalate (PET) high pressure balloon cannot be heat
or laser bonded to a polyethylene (PE) shaft because
their melt points are not compatible. For performance
reasons a shaft and balloon made of thermally
dissimilar materials which cannot be heat or laser
bonded to the balloon may be desirable. The advantage
of adhesive bonds is a common bonding method for
thermally dissimilar materials.
U.S.P.N. 4,406,653 to Nunez discloses a method and
apparatus for a catheter-balloon assembly wherein the
catheter balloon is mounted on the catheter by means of
adhesive and, in the preferred mode, an annular internal
rib protrusion of the catheter balloon is provided for
forming a sharply defined boundary of adhesive thereby
aiding in the even and symmetrical inflation of the
catheter balloon.
Concentric bonding of coaxial shafts often results
in eccentric, inconsistent bonds which can result in
bond failure. Some devices use a manufacturing fixture
to align the coaxial shafts. External fixtures
typically hold the outer diameters of the two shafts and
insert one into the other. Shaft diameter, wall
thickness and concentricity variation can still result
in inconsistent bonds.
Adhesives may wick past the end of the shaft into
an unintended lumen. To remedy this some adhesive bonds
are lengthened to minimize the chance of the adhesive
wicking past the end of the lumen. The presence of an
elongate stiff section of adhesive can be a disadvantage
with respect to catheter flexibility and trackability.
The shorter the bond the easier it is to negotiate a
tortuous path. What is needed is a balloon bond which
minimizes bond length and thereby optimizes flexibility
as well as withstands internal pressure of at least
3.4MPa (500 psi) without leaking or rupturing and which
is relatively easy, consistent and reliable to
manufacture.
The above features and advantages of the present
invention, as well as others, are accomplished by
providing, according to one aspect a medical catheter
comprising:
According to another aspect, there is provided a
medical catheter comprising:
Preferred embodiments of the invention will now be
described by way of example only, with reference to the
accompanying drawings.
The present invention provides a catheter balloon
proximal or distal bond stopper which minimizes bond
length while reliably withstanding internal pressures of
at least 3.4MPa (500 psi) pressure without leaking or
rupturing and which is relatively easy, consistent and
reliable to manufacture. Figures 1 - 2 are longitudinal
cross-sectional views of a high pressure balloon
catheter adapted for use in percutaneous transluminal
coronary angioplasty (PTCA). Fig. 1 represents the
proximal bond stopper 30. Fig. 2 represents the distal
bond stopper 50.
The proximal and distal bonds set forth herein were
designed to solve problems resulting from the bonding of
coaxial shafts. The bonds centre the two shafts which
results in a uniform concentric alignment. The
"positive stop" provided by a stopper is important to
obtain a uniform gap into which adhesive can be
dispensed. The invention also serves to stop the flow
of adhesive past a defined point which is critical in
balloon bonding since the presence of adhesive in the
balloon/shaft area can adversely affect balloon
in/deflation and balloon burst strength. A setback
between the stopper and the end of the balloon cone
increases the burst strength of the balloon and is
necessary for high pressure balloons.
Since most catheter concentric proximal bonds of
coaxial shafts have bond gaps of less than 0.125mm (.005
inches) between the distal end of the catheter shaft and
the proximal end of the balloon tail, thin, low
viscosity adhesives are typically used. The thinner the
adhesive, the more important the use of the bonding
stopper. With the present proximal bonding stopper 30
and distal bonding stopper 50, the bond length is
controllable and therefore repeatable and more reliable.
Without a uniform bond, the adhesive may flow past the
desired bond length and may result in a blocked shaft
and in/deflation problems.
The balloon 35 seen in Fig. 1 comprises shaft
tubing 80 made of 50% HDPE / 50% LDPE, a coaxial inner
guidewire shaft 70 made of HDPE defining a guidewire
lumen 65 and a balloon 35 made of any material suitable
for high pressures above 1.2 x 106 (12 atm) such as PET,
PET blends or Nylon. The balloon 35 necks are trimmed to
between approximately 1.5 mm to 4.0 mm at the proximal
and distal ends. Bonding surfaces may be plasma treated
to facilitate bonding.
To prevent adhesive leakage into the balloon 35 a
proximal bond stopper 30 and/or a distal bond stopper 50
may be used. The stoppers 30, 50 form a slight
interference fit with the balloon 35 and can be made
from any conventional adhesive suitable for balloon
bonding, or from any conventional radiopaque materials
or from any heat shrinkable materials. The bond stoppers
30 or 50 can also be made by using a preform.
The dimensions of the stoppers 30, 50 whether they
be radiopaque, heat shrinkable, adhesive or preform,
will depend on the size of the catheter shaft 80 outer
diameter, the guidewire shaft 70 outer diameter and the
proximal balloon cone proximal end 55 and the distal
balloon cone distal end 60 inner diameters. The
difference between the proximal balloon cone proximal
end 55 inner diameter and the catheter shaft 80 outer
diameter gives the approximate thickness of the proximal
bond stopper 30. The difference between the distal
balloon cone distal end 60 inner diameter and the
guidewire shaft 70 outer diameter gives the approximate
thickness of the distal stopper 50. A typical stopper
30, 50 will range in thickness between 0.075mm and
0.225mm (.003 inches and .009 inches). Typically the
LDPE shaft 80 which defines the inflation lumen 25 has a
outer diameter of 0.8875mm (.0355 inches) and an inner
diameter of 0.7mm (.028 inches). The guidewire shaft 70
typically has an outer diameter of 0.575mm (.023 inches)
and an inner diameter of 0.425mm (.017 inches) to
accommodate 0.35mm (.014 inch) guidewires.
The setback 15 or 45 is advantageous because it is
reduces the difference in thickness, hardness or
stiffness between the relatively stiff high pressure
balloon 35 material and the relatively soft PE shaft 80.
Abrupt changes in transition result in areas where
kinking is likely. Additionally, bond strength is
improved because the setback 15, 45 provides a longer
"lever" or effective cone angle. The longer the setback
15, 45, and the longer the balloon cone angle, the less
will be the peel force of the balloon neck separating
from the shaft when under high pressure. Using a
proximal bond setback 15 is more important than using a
distal bond setback 45 as the proximal bond typically
bursts before the distal bond does. This is because
typically the proximal balloon neck wall thickness is
thinner than the distal neck wall thickness and
therefore is not as strong. The difference in wall
thickness results from the proximal balloon neck inner
diameter being typically larger than the distal neck
inner diameter. Typically the proximal balloon neck is
sized to fit the catheter guidewire shaft and inflation
shaft whereas the distal balloon neck is sized to fit
only the guidewire shaft. When the balloon is formed
this difference in diameter results in wall thickness
difference. The distal bond setback 45 is also less
critical than the proximal bond setback 15 since for
geometry reasons it is advantageous to eliminate
anything that is unnecessary in the distal tip region so
as to reduce tip length and profile.
If a heat shrinkable material is used for stoppers
30, 50 such as PE, the stoppers 30, 50 are heat shrunk
using any conventional means. Adhesive stoppers may be
less preferred than heat shrinkable stoppers if the
adhesive viscosity is such that it creates the potential
for adhesive migration before the adhesive dries. To
reduce the likelihood of adhesive migration, adhesives
with a viscosity which approaches a gel are preferred.
If radiopaque materials such as platinum, iridium, gold,
gold plated metal or combinations thereof, are used for
stoppers 30, 50 they can be adhesively bonded to the
catheter shaft 80 and to the guidewire shaft 70
respectively by using conventional cyannoacrylates as
described below. The advantage of radiopaque stoppers
is that the physician can flouroscopically view the
progress of the balloon.
To create adhesive stoppers a fast curing adhesive
such as cyanoacrylate e.g., Loctite® 4061, a medical
grade adhesive manufactured by Loctite Corp. in Hartford
CT is used. The preferred adhesive would require only
one application and would be cured instantly. Loctite®
447 (600 cP) is suitable for forming the stopper in one
application. Other possible Loctite® adhesives include
454 (gel), 4981 (700 cP), 4161 (1500 cP), 3091 (6000
cP), 3321 (5000 cP), 3211 (1000 cP). Dymax ® Corporation
of 51 Greenwoods Rd., Torrington, CT has ultraviolet
(UV) adhesives which may also be suitable.
The adhesive stoppers 30, 50 could be created using
a conventional means such as a rotating fixture.
Adhesive will be dispensed onto the catheter shaft 80 or
onto the guidewire shaft 70 which is rotated through 360
degrees to create a complete uniform ring of adhesive
approximately 0.5 mm wide. Create an adhesive stopper
30, 50 on the shaft tubing 80 or guidewire shaft 70
respectively which is approximately 0.002 mm high around
the circumference. It is important for the shaft 70, 80
to continue rotating several seconds after dispensing
the adhesive to ensure uniform application until the
adhesive reaches "fixture-cure" or "complete-cure" and
is dry. If UV adhesive is used, activate the
ultraviolet light source.
To create a preform stopper 30, 50 one could use a
radiopaque marker band which is preformed to a desired
dimension or a polymer or elastomer o-ring or band that
is premolded or extruded to the desired dimension.
Regardless of the stopper material used (heat
shrinkable, radiopaque, adhesive or preform), the
following applies. The stoppers 30, 50 should be
trimmed to a length of approximately .5 mm plus or minus
.25 mm. The distal 1.5 mm of the balloon proximal tail
is placed over the distal end of the distal shaft tubing
80. The proximal bond 5 area proximal to the proximal
bond stopper 30 is filled with enough adhesive to fill
the 0.05mm - 0.075mm (0.002 -0.003 inch) gap between the
proximal end of the proximal stopper 30 and the proximal
end of the balloon proximal tail 75. UR-0531 or UR-2187
can be used and is available from H.B. Fuller of St.
Paul, Minnesota. The distal 1.5 mm of the balloon distal
tail 85 is placed over the distal end of the guidewire
shaft tubing 70. The distal bond 10 area proximal to
the distal bond stopper 50 is filled with enough
adhesive to fill the 0.05mm - 0.075mm (0.002 - 0.003
inch) gap between the proximal end of the distal stopper
50 and the proximal end of the balloon distal tail 85.
UR-0531 or UR-2187 can be used available from H.B.
Fuller of St. Paul, Minnesota. More adhesive (such as
UR-0531 or UR-2187 available from H. B. Fuller) is added
to form a proximal bond adhesive fillet 40 and a distal
bond fillet 20 which is from about .75 mm long to about
1 mm long. The fillets 20 and 40 taper down to the
distal end of the guidewire shaft 70 and down to the
shaft tubing 80 respectively.
The preceding specific embodiments are illustrative
of the practice of the invention. It is to be
understood, however, that other expedients known to
those skilled in the art or disclosed herein, may be
employed without departing from the appended claims.
Claims (10)
- A medical catheter comprising:a catheter shaft (80) defining an inflation lumen (25), the catheter shaft having an inner diameter, outer diameter, proximal end and distal end;a guidewire shaft (70) defining a guidewire lumen (65), the guidewire shaft being coaxial with the catheter shaft, the guidewire shaft running longitudinally through the catheter shaft and extending distally beyond the distal end of the catheter shaft;an inflatable balloon (35) having a proximal tail having an inner diameter, a distal tail having an inner diameter, the proximal tail being mounted on to the distal end of the catheter shaft (80), the distal tail being mounted on to the guidewire shaft (70), the balloon being in fluid communication with the inflation lumen (25);a stopper means (30) sealingly affixed between the outer diameter of the catheter shaft and the inner diameter of the proximal tail, the stopper means being annular in shape and being in length shorter than the proximal tail and being of uniform circumferential thickness; andan adhesive sealing a portion (5) of the proximal tail, which is proximal to the stopper means, to the catheter shaft.
- The medical catheter of claim 1 wherein the stopper means (30) is set back (15) proximally of the proximal end of the proximal cone by at least approximately 0.25 mm.
- The medical catheter of claim 1 or 2 also comprises a proximal fillet (40) made from an adhesive material placed at the proximal end of the proximal balloon tail, the proximal fillet tapering down from the proximal tail to the catheter shaft.
- A medical catheter comprising:a catheter shaft (80) defining an inflation lumen (25), the catheter shaft having an inner diameter, outer diameter, proximal end and distal end;a guidewire shaft (70) defining a guidewire lumen (65), the guidewire shaft being coaxial with the catheter shaft, the guidewire shaft running longitudinally through the catheter shaft and extending distally beyond the distal end of the catheter shaft;an inflatable balloon (35) having a proximal tail having an inner diameter, a distal tail having an inner diameter, the proximal tail being mounted at the distal end of the catheter shaft (80), the distal tail being mounted on the guidewire shaft (70), the balloon being in fluid communication with the inflation lumen (25);a stopper means (50) being sealingly affixed between the outer diameter of the guidewire shaft and the inner diameter of the distal tail, the stopper means being annular in shape and being in length shorter than the distal tail and being of uniform circumferential thickness; andan adhesive sealing a portion (10) of the distal tail, which is distal to the stopper means, to the catheter shaft.
- The medical catheter of claim 4 wherein the stopper means (50) is set back distally of the distal end of the distal cone by at least approximately 0.25 mm.
- The medical catheter of claim 5 or 6 wherein a distal fillet (20) of adhesive material is placed at the distal end of the distal balloon tail, the distal fillet tapering down from the distal tail to the guidewire shaft.
- The medical catheter of any preceding claim wherein the stopper means (30,50) is made from an adhesive material.
- The medical catheter of any of claims 1 to 3 wherein the stopper means (30,50) is made from a heat shrinkable material.
- The medical catheter of any of claims 1 to 3 wherein the stopper means (30,50) is made from a radiopaque material.
- The medical catheter of any preceding claim wherein the stopper means (30,50) is not more than approximately 0.75 mm in length.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US762637 | 1996-12-09 | ||
US08/762,637 US5876376A (en) | 1996-12-09 | 1996-12-09 | Catheter balloon bonding stopper |
Publications (1)
Publication Number | Publication Date |
---|---|
EP0846472A1 true EP0846472A1 (en) | 1998-06-10 |
Family
ID=25065663
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP97309826A Withdrawn EP0846472A1 (en) | 1996-12-09 | 1997-12-05 | Catheter balloon bonding stopper |
Country Status (2)
Country | Link |
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US (1) | US5876376A (en) |
EP (1) | EP0846472A1 (en) |
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US6447462B1 (en) | 2000-02-15 | 2002-09-10 | Clinical Innovation Associates, Inc. | Urodynamic catheter and methods of fabrication and use |
WO2001060249A1 (en) * | 2000-02-15 | 2001-08-23 | Clinical Innovation Associates, Inc. | Urodynamic catheter and methods of fabrication and use |
EP2314341A1 (en) * | 2001-12-20 | 2011-04-27 | Boston Scientific Limited | Catheter having an improved balloon-to-catheter bond |
WO2003053508A1 (en) * | 2001-12-20 | 2003-07-03 | Boston Scientific Limited | Catheter having an improved balloon-to-catheter bond |
JP2005512694A (en) * | 2001-12-20 | 2005-05-12 | ボストン サイエンティフィック リミテッド | Catheter with improved balloon-catheter coupling |
US6923787B2 (en) | 2001-12-20 | 2005-08-02 | Scimed Life Systems, Inc. | Catheter having an improved balloon-to-catheter bond |
US7048713B2 (en) | 2001-12-20 | 2006-05-23 | Scimed Life Systems, Inc. | Catheter having an improved balloon-to-catheter bond |
US8449497B2 (en) | 2001-12-20 | 2013-05-28 | Boston Scientific Scimed, Inc. | Catheter having an improved balloon-to-catheter bond |
US7914486B2 (en) | 2001-12-20 | 2011-03-29 | Boston Scientific Scimed, Inc. | Catheter having an improved balloon-to-catheter bond |
WO2009059609A1 (en) * | 2007-11-06 | 2009-05-14 | Coloplast A/S | Balloon catheter |
US8221485B2 (en) | 2008-03-05 | 2012-07-17 | Biotronik Vi Patent Ag | Catheter and system for introducing an intraluminal endoprosthesis |
DE102008012744A1 (en) * | 2008-03-05 | 2009-09-10 | Biotronik Vi Patent Ag | Catheter and system for introducing an intraluminal endoprosthesis |
US8360988B2 (en) | 2008-10-24 | 2013-01-29 | Innerspace, Inc. | Catheter air management system |
US8876729B2 (en) | 2008-10-24 | 2014-11-04 | InnerSpace Neuro Solutions, Inc. | Catheter air management system |
US8021330B2 (en) | 2008-11-14 | 2011-09-20 | Medtronic Vascular, Inc. | Balloon catheter for crossing a chronic total occlusion |
WO2010056879A1 (en) * | 2008-11-14 | 2010-05-20 | Medtronic Vascular Inc. | Balloon catheter for crossing a chronic total occlusion |
US10123723B2 (en) | 2014-03-10 | 2018-11-13 | InnerSpace Neuro Solutions, Inc. | Air line protection coupling for a catheter |
US10687720B2 (en) | 2014-06-09 | 2020-06-23 | Irras Usa, Inc. | Automatic air management system |
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